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Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human Papilloma Virus). This condition is common, especially in immunodepressed patients.
These lesions are not accessible to topical medical treatment because of their location. They should be treated surgically because they may degenerate into squamous cell carcinoma.
In the operating room, lesions are identified by a complete proctologic examination, more or less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration (dysplasia) in the form of intense bleaching. The interpretation of this test may nevertheless be difficult in case of local inflammation or scarring. These false positives may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy or destruction of the condylomatosis by electrocoagulation.
The acetic acid test is used at the discretion of the surgeon. However, there is little data on its performance or consensus on its use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acetic acid test | Other | Patients will receive surgical treatment for anal condylomatosis and acetic acid on the mucosa of the anal canal before the surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetic acid test | Procedure | Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value of the acetic acid test in comparison with the anatomopathological analysis of the biopsies performed on the lesions revealed by acetic acid | Application of acetic acid just before surgery to identify suspect areas of dysplasia. Biopsies of suspicious areas bleached with acetic acid. The true positives (TP) will correspond to lesions bleached by acetic acid and showing dysplasia at biopsy. False positives (FP) will correspond to lesions bleached by acetic acid but not showing dysplasia at biopsy. The positive predictive value (PPV) will be the proportion of TP over the total number of bleached lesions. (PPV = TP / (TP + FP)). The PPV will be given with its 95% confidence interval (95%CI). | the day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the toxicity of the acetic acid test | Collection of adverse events associated with acetic acid use in peroperative time | the day of surgery |
| Identify a patient subgroup in which the acetic acid test would be particularly discriminatory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Darnis | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital de la Croix Rousse | Lyon | 69004 | France |
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Pre-surgery data collection on patient file at pre operative visit
| up to 5 months before surgery |
| post-surgery pain | self-assessed using a visual analog scale at 5; 12 hours post surgery;at Day 1; Day 2 ; Day 3; Day 7 ; Day 14; Day 21 post surgery; 1 month post-surgery | up to 1 month post surgery |
| change in post-surgery incontinence | evaluation with the Wexner score (anal incontinence score used internationally) before surgery (at pre operative visit) and 1 month post-surgery | up to 5 months before surgery and 1 month post surgery |
| Clinical recurrence of anal condylomatosis | 1 month post surgery |
| Duration of sick leave | number of days of sick leave | 1 month post surgery |
| Number of unscheduled medical visits | 1 month post surgery |